This trial is active, not recruiting.

Conditions ovarian neoplasms, brca1 protein, brca2 protein
Treatment ku-0059436 (azd2281)(parp inhibitor)
Phase phase 1
Sponsor AstraZeneca
Start date July 2005
End date December 2008
Trial size 95 participants
Trial identifier NCT00516373, D0810C00002, KU36-92


To determine the safety, tolerability, dose-limiting toxicity (DLT), pharmacokinetic-pharmacodynamic profile, and maximum tolerated dose (MTD) of KU-0059436 when administered orally to patients with advanced solid tumours. To further evaluate the safety and efficacy of KU-0059436 in an expanded cohort of BCRA-enriched population, primarily ovarian cancer patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
KU-0059436 administered orally twice daily
ku-0059436 (azd2281)(parp inhibitor) Olaparib

Primary Outcomes

To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436
time frame: assessed at each visit

Secondary Outcomes

Objective tumour response
time frame: assessed every 8 weeks

Eligibility Criteria

Male or female participants from 18 years up to 130 years old.

Inclusion Criteria: - Confirmed malignant advanced solid tumour refractory to standard therapy or for which no suitable effective standard therapy exists. Exclusion Criteria: - Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the agents used).

Additional Information

Official title A Phase I, Pharmacokinetic and Biological Evaluation of a Small Molecule Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP-1), KU-0059436, in Patients With Advanced Tumours.
Principal investigator Dr. Johann De Bono, PhD MRCP FRCR
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.